U.S. patent number 6,786,919 [Application Number 09/901,993] was granted by the patent office on 2004-09-07 for self-expanding intravascular device with protector members.
This patent grant is currently assigned to Endovascular Technologies, Inc.. Invention is credited to Arnold M. Escano, Shuji Uemura.
United States Patent |
6,786,919 |
Escano , et al. |
September 7, 2004 |
**Please see images for:
( Certificate of Correction ) ** |
Self-expanding intravascular device with protector members
Abstract
Protector elements for use in combination with medical devices
configured to repair vasculature or other body lumens. In one
aspect, the protector elements embody a cuff which provides a
medical device with atraumatic surface and a desirable profile. In
another aspect, the protector elements provide a medical device
with enhanced structural integrity.
Inventors: |
Escano; Arnold M. (Santa Clara,
CA), Uemura; Shuji (San Francisco, CA) |
Assignee: |
Endovascular Technologies, Inc.
(Santa Clara, CA)
|
Family
ID: |
32928163 |
Appl.
No.: |
09/901,993 |
Filed: |
July 10, 2001 |
Current U.S.
Class: |
623/1.13;
606/194; 623/1.53 |
Current CPC
Class: |
A61F
2/90 (20130101); A61F 2220/0075 (20130101) |
Current International
Class: |
A61F
2/06 (20060101); A61F 002/06 () |
Field of
Search: |
;623/1.13,1.15,1.32,1.34,1.36,1.53,1.16 ;606/191,194,195,198 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Willse; David H.
Assistant Examiner: Blanco; Javier G.
Attorney, Agent or Firm: Fulwider Patton Lee & Utecht,
LLP
Claims
What is claimed is:
1. A medical device, comprising: a body portion having a first end
portion and a second end portion and being defined by a structure
including a plurality of pairs of converging struts; a first cuff,
the first cuff being attached to the first end portion; a second
cuff, the second cuff being attached to the second end portion; at
least one shoe device, the shoe being configured at one pair of
converging struts to maintain the struts in a spaced relationship;
and wherein the first and second cuffs and the shoe device provide
the medical device with atraumatic surfaces and a streamlined
profile and wherein the shoe device permits the conveying struts to
slide with respect of each other.
2. The device of claim 1, the first cuff further comprising an
annular space.
3. The device of claim 2, wherein the first cuff is configured to
receive a portion of the body portion and to engage both an
interior and an exterior segment of the body portion.
4. The device of claim 1, the second cuff further comprising an
annular space.
5. The device of claim 4, wherein the second cuff is configured to
receive a portion of the body portion and to engage both an
interior and an exterior segment of the body portion.
6. The device of claim 1, wherein the first cuff is configured to
reside within an interior of the body portion.
7. The device of claim 1, wherein the second cuff is configured to
reside within an interior of the body portion.
8. The device of claim 1, wherein the body portion is radially
collapsible and the first and second cuffs cooperate to collapse
with the body portion.
9. The device of claim 1, wherein the first and second cuffs are
sutured to the body.
10. The device of claim 1, wherein the first and second cuffs are
made from graft material.
11. The device of claim 10, wherein the graft material is PTFE.
12. The device of claim 10, wherein the graft material is PE.
13. The device of claim 1, wherein the shoe device provides the
body portion with structural integrity.
14. The device of claim 1, wherein the shoe device if formed from a
plastic material.
15. The device of claim 1, the shoe device further comprising a
plurality of through holes which are sized to receive a section of
strut.
16. The device of claim 15, wherein the plurality of through holes
extend through a length of the shoe device.
17. The device of claim 1, further comprising a plurality of
through holes, wherein the plurality of holes have blind ends.
18. The device of claim 1, wherein the shoe device is configured at
converging struts located at a medial portion of the body
portion.
19. A medical device, comprising: a body portion having a first end
portion and a second end portion and being defined by a structure
including a plurality of pairs of converging struts; a first cuff,
the first cuff being attached to the first end portion; a second
cuff, the second cuff being attached to the second end portion; and
at least one shoe device, the shoe device being configured at one
pair of converging struts to maintain the struts in a spaced
relationship: wherein the first and second cuffs provide the
medical device with atraumatic surfaces and a streamlined profile
and wherein the shoe device permits the converging struts to slide
with respect to each other.
Description
BACKGROUND OF THE INVENTION
The present invention relates to devices for repairing body lumens
and more particularly, to self-expanding braided or mesh devices
for support or repair of vasculature.
The vasculature of an animal or a human characteristically suffers
from a variety of maladies. Vessel walls can weaken and become
distended over time in response to blood flow and pressures,
thereby resulting in formation of aneurysms. Such aneurysms can
take on a myriad of forms. In particular, aneurysms may form at or
near bifurcated vessels creating enlarged areas about the
bifurcation, or may form a pocket, for example, in side walls of
vessels. Due to the complications associated with aneurysms that
rupture or otherwise fail, it is critical that an aneurysm be
treated expeditiously and effectively. Intravascular treatment
procedures include placing grafts within the aneurysm in a manner
to ensure that blood flows through the graft rather than through
the weakened vessel.
Stenoses also typically form in vasculature of humans and animals.
Specifically, thrombotic or atherotic stenoses can form nearly
anywhere in the vasculature. Such narrowing of the vessel is, of
course, highly dangerous to the patient where the afflicted vessel
provides the sole blood flow access to critical parts of the body.
To treat such stenoses, a supporting structure can be placed at the
diseased site for the purpose of enlarging and holding open the
vessel. It is known in the art to employ stents for this
purpose.
Vessel occlusions can also be treated by employing devices which
are actuated to debulk and remove vessel occluding thrombi. This
procedure is generally referred to as a thrombectomy. Typically,
such devices are intravascularly advanced to the repair site and
manipulated to remove the unwanted material from the vessel by
physically engaging the thrombus and severing the same from the
vessel wall.
Due to procedures such as thrombectomies or due to the natural,
albeit undesirable, function of a patient's vasculature, emboli may
be found traveling through a blood vessel. Embolic material can
cause unwanted blockages or otherwise facilitate the formation of
an occlusion in a vessel which too, can be highly dangerous to a
patient. To address this problem, emboli-catching filters can be
intravascularly placed within vasculature to thereby provide
embolic protection. Such devices are often implanted temporarily
within vasculature and removed upon being satisfied that the
undesirable embolic material has been captured.
In certain situations, it is desirable to aid the formation of
thrombus. For example, devices may be placed within aneurysmal
spaces to slow and eventually cease blood flow therethrough. This
procedure is sometimes referred to as embolic therapy, the basic
thrust of which is to minimize or eliminate exposure of weakened
sections of vasculature to blood flow and pressure.
Unfortunately, many of the devices intraluminally inplanted into
the vasculature or other body lumens of a patient may cause
additional trauma to already injured blood vessels. Whether
self-expanding or plastically deformable, stents characteristically
have an open mesh construction, or are formed with multiple
openings to facilitate radial expansion and reduction and to permit
tissue ingrowth in and around the mesh structure. Conventional
devices can lack a profile suited to avoid traumatic engagement
with a vessel wall. The wire ends of the mesh or braided structure
may be sharp and hard and may cause trauma to the vessel wall. In
addition, the ends as well as the intersections or crossings of the
mesh or braided structure may attract blood platelets and
therefore, cause thrombosis.
Additionally, certain of conventional mesh or braided structures
can lack sufficient structural integrity for a particular purpose.
That is, members defining the mesh or braided structures can be
translated in response to a load which thereby minimizes the
effectiveness of the repair devices. Accordingly, in such
applications, structures having higher structural strength may be
desirable.
Hence, those concerned with repair of diseased vasculature or other
body lumens have recognized the need for devices that can be
employed to retain the patency of a lumen or otherwise effectively
repair the lumen without causing additional trauma. The present
invention fulfills these needs.
SUMMARY OF THE INVENTION
Briefly, and in general terms, the present invention is directed
towards devices contemplated for the repair or support of
vasculature or other body lumens. Basically, the invention is
directed to protector elements for use in combination with medical
devices. In one aspect, the present invention includes a
self-expanding, cyclindrical braided or mesh structure that is
characterized by having protector elements either on the ends or at
the junctions of the wire strut elements defining the braided or
mesh structure, thereby presenting surfaces that are atraumatic to
vessel walls or defining a structure with a streamlined profile and
an enhanced structural integrity.
The structure of the present invention is referred to as a braid or
a mesh. Braiding is the interlacing of wire sections at various
angles to each other to form a braid. It is also within the scope
of this invention to interweave or overlay strands of material, as
in a mesh or a screen. It is to be recognized, however, that the
disclosed protector elements can be used in combination with
medical devices embodying various different types of structures not
including a mesh or braided pattern, such as a framework cut from a
tube.
In one preferred embodiment, the devices of the present invention
are fabricated from a self-expanding, cylindrical structure defined
by strut elements forming a braid or mesh. The cylindrical braided
or mesh structure is attached to a protector element in the form of
graft ends or cuffs, employing a means for attachment, such as a
suture that attaches the cuff to each end of the braided structure.
The cuff may cover the end of the braided or mesh structure by
encasing it in an annular space forming a channel or shelf around
the inner and outer surfaces of the end of the braid or mesh. The
cuff may also be attached inside of the braid end, forming a single
layer. Either as a double layer or as a single layer, the cuff
presents a surface that is atraumatic to vessel walls. In one
preferred embodiment, a woven polyester graft is used with a 3-OT
polyester suture to attach the graft to a braided stent.
Alternatively, the end or cuff may be made of plastic.
It is common procedure following the deployment of a braided or
mesh structure to either move a balloon catheter or other
components of a delivery system distally from the proximal end of
the braid or mesh or insert a catheter or an angiocatheter from the
distal end of the braid or mesh. During this procedure, it has been
noted that the braided wire ends in a conventional structure may
interfere with the devices being inserted. The graft ends or cuffs
of the invention serve to keep the wire ends away from the lumen so
that the ends do not interfere with the catheter or other devices
placed through the lumen of the braided structure.
In addition, by adding a cuff to the ends of a braided structure,
the potential inward bending of the braided or mesh wire ends noted
in conventional structures may be prevented. If the cuff is
attached inside of the braid end, forming a single layer on the
inside, the exposedbraid wires on the outside may still function to
facilitate adhesion to the vessel. The exposed wires may also
provide the radial force and the structural support if the braid is
placed inside a cuff where there is less of a concern with
interference with medical devices placed through the braid.
In another preferred embodiment, the braided or mesh structure
composed of strut wires has protector members or shoes attached to
the ends or junctions of the adjacent strut wires. In another
aspect of the invention, the protector members or shoes connect or
secure the intersecting or adjacent wires of the device. The
protector members or shoes serve to protect the junctions of the
strut wires, maintain the structural integrity of the device, and
present a surface that is atraumatic to vessel walls.
In one embodiment, the protector members or shoes may be made of
plastic. In another embodiment, the protector members or shoes may
be made of metal or other materials.
The disclosed self-expanding, braid or mesh devices with graft
ends, cuffs, or other protector members are intended for use in
addressing various maladies affecting vasculature. In particular,
the self-expanding, braided or mesh devices with protector members
can be configured specifically to facilitate the repair of
aneurysms and stenoses.
These and other objects and advantages of the invention will become
apparent from the following more detailed description, when taken
in conjunction with the accompanying drawings of illustrative
embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the braided or mesh device with end
cuffs of the present invention;
FIG. 2 is an exploded view of the assembly shown in FIG. 1;
FIG. 3 is a partial perspective view of the components shown in
FIG. 2 in an assembled configuration;
FIG. 4 is a partial view of the braided or mesh device with end
cuffs secured by sutures to the braided or mesh device;
FIG. 5 is an exploded view depicting a braided or mesh device and
an alternative embodiment of an end cuff;
FIG. 6 is a partial perspective view depicting the components shown
in FIG. 5 in an assembled configuration;
FIG. 7 is an enlarged view of a portion of a braided or mesh device
with protector members or shoes at junction points and
intersections of wire struts of the braided or mesh device;
FIG. 8 is an enlarged side view of a protector member or shoe at an
intersection of the wire struts medial ends of the braided or mesh
device of FIG. 7; and
FIG. 9 is an enlarged side view of a protector member or shoe at an
end junction point of wire struts of the braided or mesh device of
FIG. 7.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in the drawings, which were included for purposes of
illustration and not by way of limitation, the present invention is
directed towards protector elements for medical devices and in
particular, for graft or stent devices. Although the protector
elements are shown in combination with a braided or mesh type of
medical device, the same can be used to provide various other types
of medical devices with a atraumatic surfaces or well-defined
intersection or converging members to thereby define a device with
a desirable profile.
With reference to FIG. 1, there is shown a medical device 10
equipped with a first cuff 12 attached to a first terminal end
portion 14 and a second cuff 16 attached to a second terminal end
portion 18. As stated, the medical device 10 can assume a myriad of
forms and can, for example, define a bifurcated or trifurcated
configuration as well as tubular shape. The cuffs 12, 16 provide
the medical device 10 with atraumatic ends which operate to
minimize damage to body lumens or other areas in which the medical
device is used in a patient. The cuffs 12, 16 can also provide the
medical device with a profile well suited for receiving auxilliary
components therethrough.
In a preferred embodiment, the medical device 10 is defined by a
body 20 having a braided or mesh structure. In the conventional
devices employing a braided or mesh structure, the ends 24 of the
wire or elongate elements 28 (see FIG. 2, for example) used to
create such structures are often left exposed. When implanting
these conventional structures within a patient, for example, within
vasculature, the exposed ends are left to directly engage walls
defining vasculature or are otherwise left to interfere with blood
flow or other medical devices used at the repair site.
Consequently, the exposed ends can cause damage to tissue during
implantation, repositioning, or after implantation during the
natural movement of the tissue. That is, when used in vasculature,
for example, pulsation of a vessel in response to the blood flow
can cause the exposed ends to injure the vessel. Also, when used in
vasculature, easy access through a lumen defined by the medical
device may be required so that the guidewires or balloon catheters
can be advanced therethrough. To wit, medical devices embodying
sharp end portions or other structures projecting radially inwardly
can act as an obstruction.
By equipping the medical device 10 with a cuff 12 as shown in FIGS.
2-4, the medical device 10 can be configured with atraumatic ends
as well as a profile well suited for receiving additional medical
device therethrough. In one aspect, the cuff 12 is generally
cylindrical and includes an internal bore 30. The cuff additionally
includes an annular space 32 for receiving an end portion 24 of a
body 20 of the medical device 10 of the present invention. An
entrance 34 to the annular space is provided at a first end 36 of
the cuff 12. In a preferred embodiment, the second end 38 is closed
to thereby define an annular space 32 having a blind end.
In one embodiment, the cuff 12 is made from flexible materials such
as the materials used for conventional woven grafts. That is, it
has been found that cuffs made from PTFE or PE or equivalent
materials are acceptable for providing the cuff with the desired
profile. The cuff 12 can be attached to the body 20 of the medical
device 10 by employing sutures 40, though any structures or means
for attaching the cuff 12 to a medical device 10 is acceptable.
Moreover, the cuff 12 can be configured to receive a portion of the
body 20 and to engage both an interior and an exterior segment of
the body.
By utilizing a cuff 12 with an annular space 32, the ends 24 of a
medical device 10 can be made to be atraumatic. Also, the wires or
elongate or other structures at the end of the medical device 10
can be contained so that easy delivery of the device as well as
insertion of the delivery components or other medical devices
thereafter is facilitated. Moreover, equipping the medical device
10 with the contemplated flexible cuffs 12, 16, the assembly can be
conveniently configured to assume a compressed form for
transportation through and delivery within body lumen such as
vasculature (see FIG. 4). Thus, the medical device 10 can be
compressed into a low profile and placed within or on a delivery
catheter (not shown) so that the device can both be advanced
through tortuous and small diameter spaces thereby making the
device useful in various areas of the patient's body.
In an alternative embodiment (see FIGS. 5 and 6), it is
contemplated that the cuff 50 of the present invention lack an
annular space and rather, defines a simple sleeve structure. Again,
the cuff 50 can be formed from conventional graft materials and can
be sutured or otherwise affixed 52 to ends 24 of the body 20 of a
medical device 10. The cuff 50 can be attached to an internal bore
54 of the body 20 to provide the medical device 10 with a profile
well-suited for receiving other medical devices. The ends 24 of the
medical device 10 are then left to engage the tissue into which the
medical device 10 is implanted and to provide a robust anchor
thereto. It is also contemplated that the cuff 50 can be affixed to
an external circumference of the body 20 of the medical device 10
(not shown) to provide the device with atraumatic ends where there
is less of a concern for obstruction with other devices inserted
through the medical device 10.
Turning now to FIGS. 7-10, there is shown a medical device 60
defined by intersecting or converging elongated members 62. At the
intersecting or converging points 64, 66, there are boots or shoes
70, 72. A first boot or shoe 70 can define a generally elliptical
sphere and includes a pair of through holes 80 spaced on an
exterior surface of the boot 70. Each through hole 80 is adapted to
receive an intersecting elongate member 62 and in combination,
pairs of holes 80 operate to hold the members 62 in close
proximity, but separated. The boot 70 can be designed so that the
elongate members 62 freely slide therethrough or can be made to
hold the members 62 in a fixed position relative to each other.
The boot 70 is contemplated to be made of any suitable
biocompatible plastic and as such, can be molded or machined to
specification. When the medical device 60 is in its assembled form,
the boots or shoes 70 provide the device with structural integrity
as well as provides atraumatic surfaces. Although the boots 70 are
shown as being used with a braided or weaved medical device 60, it
is contemplated that the same could be used in combination with any
medical device requiring atraumatic surfaces or additional
structural integrity.
Similarly, boots or shoes 72 can likewise be configured to receive
converging elongate member 62 positioned at an end of a medical
device 60. Such a boot 72 can be made from plastic and can be
configured with blind end apertures 82 sized to receive elongate
members 62 defining a medical device 60. It is contemplated that
the boot or shoe 72 be affixed to the elongate members 62 to
provide structural integrity as well as atraumatic ends. The
affixation can be accomplished through the use of epoxies or an
interference fit between the boot 72 and the elongate members
62.
Accordingly, the present invention provides medical devices that
minimize trauma to body tissue. Additionally, the present invention
provides medical devices with enhanced structural integrity and
present a profile adapted for use with auxilliary medical
devices.
While several particular forms of the invention have been
illustrated and described, it will be apparent that various
modifications can be made without departing from the spirit and
scope of the invention. For example, references to materials are
not intended to be limiting in any manner. Accordingly, it is not
intended that the invention be limited, except as by the appended
claims.
* * * * *